JMIR Publications

ABSTRACT

Background:

Emerging research suggests that open-source automated insulin delivery (AID) may reduce diabetes burden and improve sleep quality and quality of life. However, the evidence is mostly qualitative or uses unvalidated, study-specific, single items. Validated person-reported outcome measures (PROMs) have demonstrated the benefits of other diabetes technologies. The relative lack of research investigating open-source AID using PROMs has been considered a “missed opportunity”.

Objective:

To examine the psychosocial outcomes of adults with type 1 diabetes using and not using open-source AID systems, using a comprehensive set of validated PROMs in a real-world, multi-national, cross-sectional study.

Methods:

Adults with type 1 diabetes completed eight validated measures of general emotional well-being (WHO-5); sleep quality (PSQI); diabetes-specific quality of life (QoL) (DIDP); diabetes-specific positive well-being (4-item WBQ), diabetes treatment satisfaction (DTSQ), diabetes distress (PAID), fear of hypoglycaemia (HFS-II SF); and a measure of the impact of COVID-19 on QoL. Independent groups t-tests and Mann-Whitney U tests examined PROM scores by use of open-source AID. ANCOVA was used to adjust for potentially confounding variables, including all sociodemographic and clinical characteristics that differed by use of open-source AID.

Results:

In total, 592 participants were eligible (attempting at least one questionnaire), including 451 using open-source AID (mean±SD age 43±13 years, 42% women) and 141 non-users (age 40±13 years, 64% women). Adults using open-source AID reported significantly better general emotional well-being and subjective sleep quality, and better diabetes-specific QoL, positive well-being, and treatment satisfaction. They also reported significantly less diabetes distress, fear of hypoglycaemia and perceived less impact of the COVID-19 pandemic on their QoL. All were medium-to-large effects (Cohen’s d: 0.5 to 1.5). The differences between groups remained significant after adjusting for sociodemographic and clinical characteristics.

Conclusions:

Adults with type 1 diabetes using open-source AID report significantly better psychosocial outcomes than those not using these systems, after adjusting for sociodemographic and clinical characteristics. Using validated, quantitative measures this real-world study corroborates the beneficial psychosocial outcomes described previously in qualitative studies or using unvalidated study-specific items.